Pill Politics : : Drugs and the FDA / / Stephen J. Ceccoli.

• Superior document: Title is part of eBook package: De Gruyter Lynne Rienner Press Complete eBook-Package 2013-2000
• VerfasserIn: Ceccoli, Stephen J.,
• Place / Publishing House: Boulder : : Lynne Rienner Publishers, , [2022]; ©2004
• Year of Publication: 2022
• Language: English
• Physical Description: 1 online resource (211 p.)

From aspirin to Viagra to the latest cancer treatment, the Food and Drug Administration acts as a gatekeeper determining what medicines are legally available in the United States. But in fulfilling that regulatory role, Stephen Ceccoli argues, the FDA may inadvertently be promoting new drugs at the expense of public health.The FDA's initial mandate to protect health grew out of pharmaceutical-related disasters in the early 1900s. Later criticisms that the agency's approach impeded industry competitiveness and failed to meet public need, however, led to a political compromise on its mission. The new FDA has cut its review time nearly in half and allows direct-to-consumer advertising, off-label promotion of drugs, and the "fast-tracking" of treatments. Ceccoli convincingly shows that this approval process, while redressing valid complaints, is also creating a new complex of problems that must be resolved.

Table of Contents

Frontmatter -- Contents -- Tables and Figures -- Acknowledgments -- 1. Putting the FDA into Perspective -- 2. The Politics of Assessing Drugs -- 3. An Evolving Regulatory Balance -- 4. The Drug Lag Debate and Demands for Reform -- 5. A Grand Compromise and the Shift to a New Era -- 6. Whither the FDA? -- 7. Protecting and Promoting Public Health in the United States -- Appendix: Drug Development and the FDA’s Approval Process -- List of Abbreviations -- Notes -- Bibliography -- Index -- About the Book